On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®. Tocilizumab is a monoclonal antibody that acts as an interleukin-6 (IL-6) inhibitor to reduce inflammation in the body. The EC approved AVTOZMA® for all indications of the reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA). This approval follows Celltrion’s announcement of FDA approval for AVTOZMA® on January 31, 2025.
Celltrion is the third company to receive EC approval for a tocilizumab biosimilar, joining Fresenius Kabi and Biogen.
AVTOZMA® is Celltrion’s twelfth biosimilar to obtain marketing authorization in the European Union.
Stay tuned to Big Molecule Watch for more regulatory updates on biosimilars.